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Wrist Blood Pressure Monitor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 92021001003Model YJ110,YJ111510(k) K232815
Identity
- Trade Name
- Wrist Blood Pressure Monitor EUDAMED
- Device Name
- Wrist Blood Pressure Monitor EUDAMED
- Model / Reference
- YJ110,YJ111 EUDAMED92021001003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975039330340 EUDAMED
- Basic UDI-DI
- 697503933YJ110JY EUDAMED
- Direct Marketing DI
- 06975039330340 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wrist Blood Pressure Monitor by Zhuhai Yueja Medical Device Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232815 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697503933YJ110JY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhuhai Yueja Medical Device Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000026087
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (2)
- EUDAMED 03131db4-d617-439e-8214-b215681f6b0c 85 fields · synced Jun 18, 2026
- FDA 510(k) K232815 1 fields · synced May 18, 2026